Ahead of a pair of pivotal Phase III trial readouts expected in 2024, Relmada Therapeutics, Inc. released data from an open-label Phase III trial of REL-1017 on 20 September which it said showed clinically meaningful and sustained improvements in depression symptoms and associated functional impairment while continuing to support a safety profile that might give the NMDA antagonist an edge in the competitive depression space.
Key Takeaways
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After two Phase III failures – which the company attributes to high placebo response – Relmada hopes to boost REL-1017’s image with efficacy and safety data from an open-label study.
- Although not placebo-controlled, the open-label study showed rapid and sustained improvement at multiple timepoints on a commonly used endpoint
The drug’s prospects took a hit last October when the pivotal Phase III RELIANCE-III study failed to hit its primary endpoint of improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) on day 28, but not due to lack of activity
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